Background: Drug‐refractory atrial fibrillation ( AF ) increasingly is being treated with catheter ablation. However, the long‐term success rate, expressed as freedom from AF , is <50%. Therefore, vitamin K antagonists, with all their complications, remain necessary. Recently, left atrial appendage ( LAA ) occlusion devices were introduced as an alternative to vitamin K antagonists. Here, we investigated whether AF ablation and LAA occlusion could be a feasible and safe combination in patients with symptomatic drug‐refractory AF and a CHADS 2 score ≥1 or a contraindication for vitamin K antagonists. Methods and Results: Ablation was performed by using multielectrode catheters with phased radiofrequency energy. LAA was occluded with the Watchman device (Atritech, Inc, Plymouth, MN). Between February 2010 and February 2011, 30 patients were treated (21 male; age, 62.8±8.5 years). Median CHADS 2 score was 2.5 (25th to 75th percentiles: 2 to 3), median CHADS ‐ VAS c score was 3 (25th to 75th percentiles: 3 to 5), 77% had prior stroke, and 27% had a contraindication for vitamin K antagonists. Median HAS ‐ BLED score was 2 (range, 1 to 5). Successful device implantation was achieved with a median number of 1.5 devices (median diameter 24 mm [25th to 75th percentiles: 24 to 24 mm]). Total procedure time was 97 minutes (25th to 75th percentiles: 75 to 115 minutes). At 60 days, all patients met the criteria for successful sealing. Follow‐up visit at 12 months showed a 30% rate of documented recurrence of AF . A repeated pulmonary vein isolation was performed successfully in 4 patients, without interference of the LAA closure device. No thromboembolic events occurred during 1‐year follow‐up. Conclusion: LAA occlusion with the Watchman device and AF ablation can be combined successfully and safely in a single procedure. The Watchman does not interfere with a repeated ablation.
1 August 2014 in JACC: Cardiovascular Interventions
BACKGROUND: Approximately 15% of saphenous vein grafts (SVGs) occlude during the first year after coronary artery bypass graft surgery (CABG) despite aspirin use. The POPular CABG trial (The Effect of Ticagrelor on Saphenous Vein Graft Patency in Patients Undergoing Coronary Artery Bypass Grafting Surgery) investigated whether ticagrelor added to standard aspirin improves SVG patency at 1 year after CABG. METHODS: In this investigator-initiated, randomized, double-blind, placebo-controlled, multicenter trial, patients with ≥1 SVGs were randomly assigned (1:1) after CABG to ticagrelor or placebo added to standard aspirin (80 or 100 mg). The primary outcome was SVG occlusion at 1 year, assessed with coronary computed tomography angiography, in all patients who had primary outcome imaging available. A generalized estimating equation model was used to perform the primary analysis per SVG. The secondary outcome was 1-year SVG failure, which was a composite of SVG occlusion, SVG revascularization, myocardial infarction in myocardial territory supplied by a SVG, or sudden death. RESULTS: Among 499 randomized patients, the mean age was 67.9±8.3 years, 87.1% were male, the indication for CABG was acute coronary syndrome in 31.3%, and 95.2% of procedures used cardiopulmonary bypass. Primary outcome imaging was available in 219 patients in the ticagrelor group and 224 patients in the placebo group. The SVG occlusion rate in the ticagrelor group was 9.6% (44 of 457 SVGs) versus 10.1% in the placebo group (50 of 497 SVGs; odds ratio, 0.87 [95% CI, 0.49–1.55]; P =0.64). SVG failure occurred in 32 patients (12.9%) in the ticagrelor group versus 32 patients (13.0%) in the placebo group (hazard ratio, 1.04 [95% CI, 0.63–1.69]). CONCLUSIONS: In this randomized, placebo-controlled trial, the addition of ticagrelor to standard aspirin did not reduce SVG occlusion at 1 year after CABG. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02352402. URL: https://eudract.ema.europa.eu/ ; Unique identifier: 2014-002142-50.
4 August 2009 in European Heart Journal - Cardiovascular Imaging
We report a case of percutaneous mitral valve repair, using the Mitraclip device, in which we show that application of real-time three-dimensional transoesophageal echocardiography (3D-TEE) is extremely helpful for the guidance of this procedure. Because of its excellent visualization capacities, 3D-TEE simplifies the transseptal puncture, the positioning of the clip above the mitral valve orifice, the grasping of the mitral valve leaflets, and the evaluation of the final result. Therefore, we conclude that 3D-TEE has the potential to increase the safety and efficacy of this new technique to treat mitral regurgitation in patients who cannot undergo conventional valve surgery.
18 October 2019 in Frontiers in Cardiovascular Medicine
Mitral valve disease affects more than 4 million people in the United States and it is the second most prevalent valvulopathy in Europe. The gold standard of treatment in these patients is surgical repair or mitral valve replacement. In the last decade, numerous transcatheter therapies have been developed to overcome the increased number of subjects with symptomatic severe mitral regurgitation and high surgical risk. The Mitraclip (Abbott Vascular, Menlo Park, CA), PASCAL (Edwards Lifesciences, Irvine, CA, USA), the Carillon™ Mitral Contour System™ (Cardiac Dimension Inc., Kirkland, WA, USA), the Mitralign™ (Mitralign, Tewksbury, Massachusetts), and the Cardioband (Edwards Lifesciences, Irvine, CA) are the principal percutaneous devices for mitral valve repair. We present an evidence-based clinical update that provides an overview of these technologies and their potential complications.
1 October 2019 in The American Journal of Cardiology